Document Detail

Mifepristone and misoprostol sequential regimen side effects, complications and safety.
MedLine Citation:
PMID:  16781261     Owner:  NLM     Status:  MEDLINE    
Exhibiting a strong affinity to the progesterone and the glucocorticoid receptors, mifepristone exert competitive antagonism to these hormones both in in vitro and in animal experiments. Due to its antiprogesterone activity, it was proposed that mifepristone be used for the termination of early human pregnancy. Mifepristone, at a dose of 600 mg initially used alone, was then used with a subsequent low dose of prostaglandin that led to a success rate of 95% as a medical method for early termination of pregnancy (TOP), and the occurrence of continuing pregnancy was reduced to <or=1%. Its use was extended to other indications, such as cervical dilatation prior to surgical TOP in the first trimester, therapeutic TOP for medical reasons beyond the first trimester and for labor induction in case of fetal death in utero. The efficacy and safety of this treatment have been confirmed based on its use for over 15 years since its first approval in France and with close adherence to the approved recommendations. This article describes the toxicology studies conducted in animals as well as the safety follow-up and side effects reported with use of the compound when used with misoprostol in the main indication that is currently approved in 31 countries. Special emphasis is given to the rare but relevant safety issues, that is, heavy uterine bleeding, pelvic infections and continuing pregnancies. The rationale for warnings and contraindications for use of the product are also explained.
Regine Sitruk-Ware
Publication Detail:
Type:  Journal Article; Review     Date:  2006-05-15
Journal Detail:
Title:  Contraception     Volume:  74     ISSN:  0010-7824     ISO Abbreviation:  Contraception     Publication Date:  2006 Jul 
Date Detail:
Created Date:  2006-06-19     Completed Date:  2006-11-22     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  0234361     Medline TA:  Contraception     Country:  United States    
Other Details:
Languages:  eng     Pagination:  48-55     Citation Subset:  IM    
Center for Biomedical Research, Population Council, Rockefeller University, New York, NY 10021, USA.
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MeSH Terms
Abortifacient Agents / administration & dosage*,  adverse effects*
Abortion, Induced
Clinical Trials as Topic
Mifepristone / administration & dosage*,  adverse effects*
Misoprostol / administration & dosage*,  adverse effects*
Pelvic Infection / epidemiology
Uterine Hemorrhage / epidemiology
Reg. No./Substance:
0/Abortifacient Agents; 59122-46-2/Misoprostol; 84371-65-3/Mifepristone

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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